Re: National Specialist Commissioning Consultation on
service specifications and clinical policies

We are writing to provide formal input from our
respective National Specialist Societies in relation to the above. As you will
be aware, not only do we collectively represent virtually all cardiologists in
the UK but also the vast majority of the allied health care professionals
across the spectrum of cardiovascular disease and the national cardiovascular
patient organisation. Our comments and concerns relate to a number of areas as
follows:-

Process

The introduction of Clinical Reference Groups (CRGs) to
provide advice on National Specialist Commission was a welcome development and
both our Societies had the opportunity to nominate clinical representatives to
the relevant groups for cardiovascular medicine. We believe the CRGs had an
appropriate mix of clinical, patient and commissioning representation to
provide a balanced and structured, evidence based approach to advice given in
regard to commissioning intentions, service specifications and suitable levels
of commissioning. However, we have serious concerns about the timescales
involved and the opportunity for CRG members to have collective dialogue and
consensus agreement on the recommendations. It is clear from discussions with
representatives on the various CRGs that they undertook an enormous amount of
work within a very short timescale. Frustratingly, much of the later work
providing updated consensus documents to inform the commissioning recommendations
seem to have been ignored and there was inadequate opportunity for engagement
of the CRG members regarding the final recommendations. We believe this may
have significantly compromised some of the recommendations currently under
consultation and would strongly recommend that the CRG members have full and
appropriate engagement in the final commissioning decisions to ensure the value
and credibility of these recommendations from a clinical and patient
perspective.

Services considered and recommended for National
Specialist Commissioning

We are pleased to see that Cardiovascular Disease is to
be given a high priority for National Specialist Commissioning and particularly
welcome the inclusion of Primary Percutaneous Coronary Intervention. The
ability to provide a high quality, equitable service for such a successful
evidence based treatment requires national coordination and it is reassuring
that this has been recognised. In addition, the accompanying service
specification, which recognises the need to centralise services in centres with
a high volume of activity underpinned by evolving supporting evidence, is
important and will ensure best outcomes for patients with ST elevation
myocardial infarction. In general terms for all the nationally commissioned cardiovascular
services, the philosophy of ensuring provision of complete national audit data
through the national databases hosted by the National Institute for
Cardiovascular Outcomes Research (NICOR) is crucial and fundamental to the
future provision of continued high quality and equitable care.

Services considered and not recommended for National
Specialist Commissioning

It was disappointing to see that Patent Foramen Ovale
closure, Left Atrial Appendage occlusion, and mitral valve intervention using
MitraClip were considered but not recommended for any form of national
commissioning. Whereas, we accept that the evidence base for these
interventional is less robust than for the recommended services, it remains the
case that specific indications for these treatments still exist in a small
number of patients after careful consideration by an appropriate
multi-disciplinary team. Therefore we believe that to have no provision for
commissioning of these services is inappropriate and will seriously
disadvantage a small number of patients where there is no reasonable
alternative treatment. In addition, we believe there needs to be some
structured mechanism to inform wider provision of these services in future,
where they are justified, based on coordinated clinical research and collation
of additional data as clinical experience grows. Our views on how this might be
achieved are detailed below.

Recommendations in relation to Commissioning by
Evaluation

The investigation and management of cardiovascular
disease remains one of the most successful and rapidly developing areas of
modern medicine. Not only have new therapies and technologies resulted in
significant improvement in outcomes but the collective achievements of the
whole cardiovascular community in introducing new, evidence based treatments
such as Primary Percutaneous Coronary Intervention in a structured, coordinated
manner at a national level, underpinned by robust and clinically valuable
national audit data, is one of the major success stories of modern medicine. As
clinicians responsible for the provision of high quality care, we recognise the
potential risks of haphazard and anecdotal introduction of new technologies to
the cardiovascular field. However, there is a danger inherent in the new
national commissioning structure that could seriously undermine the ability to
bring appropriate new and potentially cost saving treatments into established
clinical practice and considerable uncertainty about how best to make this
transition. The substantial gap between acceptance of a new technology,
sufficiently safe to obtain a CE mark, and the evidence base required to fulfil
the appropriately rigorous criteria of a NICE Technology Appraisal provides a
major challenge for commissioning of future services.

Hence, for these new technologies such as those
considered but not recommended for national commissioning above, we would
strongly support the process of “Commissioning by Evaluation”, which provides a
means of bridging this gap. This would involve limited commissioning of these services
through a small number of nationally coordinated centres, working to strict
service specifications including a robust multi-disciplinary process and with
devolved responsibility for maintaining agreed commissioned levels of activity.
Importantly, the commissioning would be dependent upon completion of an agreed
national dataset hosted through NICOR. Involvement of both NICE and national
commissioners at the very inception of this process is crucial and using the
professional expertise within the national specialist societies would allow a
coordinated mechanism for evaluating and recommending suitable centres based on
the commissioned service specifications. This would ensure both appropriate
geographical spread and quality of services based on sufficient volumes to
allow continued expertise during an evaluation phase. Formal evaluation and
advice on future commissioning intentions would be undertaken through an appropriately
constituted stakeholder group. The current CRG model would seem to fulfil this requirement
although the process will need to mature. This process would not only ensure
that the small number of patients who would benefit from these technologies at
an early stage of their development would have appropriate access to them but
it would also provide invaluable outcome information on patients managed in UK
centres with the necessary expertise and governance arrangements to provide
these new technologies with a high level of expertise. To some extent this is
the model that has evolved for the introduction of both TAVI and renal
denervation which has allowed a balanced and sensible approach to national
commissioning of these services which will ultimately benefit patients.

Recommendations regarding links to research opportunities

With the introduction of new technology, the concept of
an arrangement of “Commissioning by Evaluation” would allow experience and
clinical outcomes to be properly evaluated but, in most cases, there remains a
need to address and answer a specific question which can only be achieved with
a properly structured research trial. NICE Technology Appraisals, and other
NICE Guidance is often very good at identifying areas of future research but,
as indicated above, this is often at a stage where treatments and technologies
are already embedded in clinical practice to a greater or lesser degree. With
the introduction of new technologies there is often a need for formal research
evaluation at an early stage and, in tandem with a process of “Commissioning by
Evaluation” there is a major opportunity to not only inform appropriate
research but to link to its coordination and funding. Where CRGs recognise the
need for formal research evaluation to inform the future value of a wider
commissioning strategy, linking this to the Health Technology Authority and
NIHR would allow a mechanism to develop and fund such research. This could be
developed and coordinated through the existing Clinical Study Groups hosted by
the British Cardiovascular Society and linked to the NIHR Comprehensive
Clinical Research Network Cardiovascular Specialty Group, or linked to the new
Academic Health Science Networks.

In summary, we welcome the opportunity to input to the
consultation on the National Specialist Commissioning on service specifications
and clinical policies and we support the aspiration to provide high quality
commissioning of specialist services. However, we believe there have been some
serious errors in the process which has resulted in a number of services not
being appropriately recognised and commissioned at a level which will fulfil
current evidence based needs and inform appropriate levels of commissioning in
the future. Nevertheless, we believe we have proposed a number of changes which
will not only resolve this but will serve to provide a template for future
commissioning of existing and new services as well as links to essential
research to underpin this.

As national specialist societies we are keen to
facilitate these processes in any way we can. With wide representation across
the cardiovascular spectrum we hope that this particular feedback will be given
an appropriate level of importance.